Chronic Cough
Conditions
Sponsors
Afferent Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Both healthy and chronic cough subjects who meet all of the following criteria will be included in the study: 1. Be informed of the nature of the study and have provided written informed voluntary consent; 2. Be able to speak, read, and understand English; 3. Be males or females, of any race, between 18 and 80 years of age, inclusive; 4. Have a body mass index (BMI) = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: Subjects will be excluded if any of the following apply: 1. Current smoker; 2. Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history (chronic cough subjects), or >10 pack-year smoking history (healthy subjects); 3. Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study or within 2 months prior to Screening; 4. History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks prior to Screening or prior to randomization; 5. History of opioid use within 1 week prior to Screening or prior to randomization; 6. History of pregabalin, gabapentin or thalidomide use within 2 weeks of the Screening Visit; 7. Requiring concomitant therapy with prohibited medications; 8. History or symptoms of renal disease or renal obstructive disease; 9. History of kidney/bladder stones (nephro/uro-lithiasis) within 5 years of Screening; 10. History of conditions or disorders that predispose to nephrolithiasis such Type 1 renal tubular acidosis, cystinuria, gout, hyperparathyroidism, inflammatory bowel disease (i.e., ulcerative colitis and Crohn?s disease), short bowel syndrome, or bariatric surgery; 11. History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (with the exception of 160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg; 17. Screening Heart rate 110 bpm 18. Clinically significant abnormal electrocardiogram (ECG) at Screening, including any of the following: a. QT (QTcF) interval >450 milliseconds in males, >470 milliseconds in females b. Atrial fibrillation or atrial flutter c. Second degree or third degree (complete) AV block d. Left bundle branch block (including hemiblock) e. Wolf-Parkinson-White Syndrome 19. Personal or family history of congenital long QT syndrome or family history of sudden death; 20. Cardiac pacemaker; 21. Significantly abnormal laboratory tests at Screening, including: a. alkaline phosphatase (AP), alanine aminotransferase (ALT, SGPT), aspartate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Emax response to capsaicin inhalation ED50 for capsaicin challenge ;Timepoint(s) of evaluation of this end point: Primary endpoints are evaluated during entire treatment period;Main Objective: To assess the effect of single doses of 300 mg and 50 mg AF-219 on cough reflex sensitivity to capsaicin in both healthy and chronic cough subjects; Secondary Objective: -To assess the effect of single doses of 300 mg and 50 mg AF 219 on cough reflex sensitivity to ATP in both healthy and chronic cough subjects -To determine the effect of single doses of 300 mg and 50 mg AF 219 on the urge to cough evoked by capsaicin and ATP in both healthy and chronic cough subjects -To determine the effect of single doses of 300 mg and 50 mg AF 219 on daytime cough frequency in subjects with chronic cough -To determine the effect of single doses of 300 mg and 50 mg AF 219 on cough severity VAS and urge-to-cough VAS in subjects with chronic cough -To assess the safety and tolerability of AF-219 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Primary endpoints are evaluated during entire treatment period; Secondary end point(s): Emax response to ATP inhalation ED50 for ATP challenge C2 and C5 for capsaicin challenge C2 and C5 for ATP challenge Reported urge to cough (UTC) during the cough challenges for both capsaicin and ATP Daytime cough frequency in subjects with chronic cough Daytime UTC and cough severity VAS in subjects with chronic cough | — |
Countries
United Kingdom
Contacts
Public ContactPeter Butera, Clinical Operations
Afferent Pharmaceuticals, Inc.
Outcome results
None listed